Commonly-assigned application Ser. No. 09/329,471, filed Jun. 10, 1999, describes certain rheology modifying polymers derived from acrylic acid, methacrylic acid or analogues which exhibit enhanced controlled release properties when in granulated form. Commonly-assigned application Ser. No. 09/559,687, filed Apr. 27, 2000, teaches that these granulated rheology modifying polymers are particularly well suited for making solid dosage tablets and other articles by direct compressionxe2x80x94i.e., by directly compressing a mixture of the tablet ingredients without granulating the mixture first.
It has now been found that the above technology is particularly well-suited for making tablets and other solid dosage pharmaceuticals in which N-acetyl cysteine is the active ingredient.
Thus, the present invention provides a directly-compressed, controlled release tablet or other article containing N-acetyl cysteine as the active ingredient. More particularly, the present invention provides a directly-compressed, controlled release tablet or other article containing about 25 to 80 wt. % N-acetyl cysteine, about 5 to 50 wt. % of a granulated, rheology modifying, release-controlling, slightly cross-linked polymer of acrylic acid, methacrylic acid or analogue, and optionally about 0 to 40 wt. % of an additional excipient, which preferably is a directly compressible binder.
In addition the present invention also provides new directly compressible compositions for making such tablets and articles as well as direct compression processes for forming tablets, caplets, and other solid dosage forms known to those skilled in the art.